Opportunities and limitations of recyclates in medical technology
13.11.2024
One of the European Union's declared goals is sustainable development by 2030 - a development that does not stop at the medical technology industry. According to the Corporate Sustainability Reporting Directive (CSRD), hospitals will be obliged to report on their sustainability in the coming years. Not least for this reason, recyclates are now also increasingly coming to the fore in medical technology.
As in all areas of application, the use of recyclates opens up certain opportunities, but also has its limits when it comes to patient contact. Gradical GmbH, based in Switzerland, advises medical technology companies on the choice of materials for their applications. Managing Director Lucas Pianegonda knows all about the technical and regulatory requirements and how to bring them both together. In this interview, he explains how CSRD influences companies in their decisions, which applications recyclates can be used for and what the actual added value of recyclates in medical technology is.
Mr. Pianegonda, what special challenges do you see in the use of recyclates in medical technology?
Lucas Pianegonda: One challenge is the safety and performance requirements for medical devices. The Medical Device Regulation stipulates that medical devices must be safe and efficient. The requirements for products made from recycled materials are exactly the same as for conventional virgin materials, but the implementation is largely up to the manufacturer. This means that manufacturers must produce a safe and effective medical device and have risk and quality management under control – but it is up to the distributor to decide what this looks like in detail. Nothing is prescribed, but they are not guided either. This means that quality and risk management is actually the biggest challenge with recyclates.
The second challenge is that the manufacturers of recycled plastics usually come from the waste management sector and are therefore not as close to plastics technology or medical technology. The challenge here is for the two stakeholders (recyclers and medical technology) to talk to each other and tell each other what their difficulties are and how these can be solved accordingly. The challenge for the recycler is to separate and wash the waste in such a way that the quality of the recyclate is sufficient for medical technology. This in turn has certain documentation requirements (technical data sheets, regulatory documents, etc.) that recyclers rarely have or provide on their own.
The third challenge is acceptance within the medical technology industry. The need for safety is very high and there are also entrenched opinions that the use of recyclates is not feasible. We still have some convincing to do.
Where in the healthcare sector can recyclates already be used?
Pianegonda: In principle, recyclates can be used wherever risk management permits. This means that they can be used safely and without hesitation wherever there is no direct patient contact like blood contact or similar. A typical example is a walking aid: it can be used without hesitation without exposing the patient to any risk - the greatest risk here would be that the walking aid breaks. This risk can be very well controlled by incoming and outgoing goods inspections.
On the other side of the product spectrum are long-lasting implants that remain in the body for 15 years or more. Here, there are only a handful of new product manufacturers who dare to offer implantable plastics at all. This means that if most virgin material manufacturers don't dare to make implants, we can rule out the possibility of recycled materials being used for implants at some point. But that is not really what they should be used for anyways. The application limit is somewhere between walking aids and implants. In my opinion, a good application for recyclates would be in consumer goods with short patient contact, for example. A lot of plastic is used here and you have good leverage in terms of environmental impact.
How does the CSRD influence the decisions and strategies of companies with regard to the use of recycled materials in medical technology?
Pianegonda: In principle, this regulation means that companies must measure and report their environmental impact. Step by step, they are then required to reduce their CO2 emissions. In this context, using recyclates has the advantage that they reduce the CO2 footprint of plastics – at least with mechanical solution-based recycling methods. For medical technology companies, this means that they have a lever for CO2 reduction. This is because they collect 80 to 90 percent of their CO2 emissions in Scope 3, i.e. where the supply chain and therefore the suppliers and customers fall in. This means that the materials purchased at this point can have a positive impact on the environment – and recyclates help enormously here.
To what extent do chemical, solvent-based and mechanical recycling play a role in medical technology?
Pianegonda: First of all, it is important to note that recyclates are used to reduce CO2 and not for the sake of using recycled plastics. The aim is to minimize the environmental impact. This means that the recycling method or the plastic must always be selected in such a way that the environmental impact is minimized. Chemical recycling delivers the best quality, but with the highest environmental impact. In my opinion, solvent-based recycling would be more promising. However, there are only a few companies that do this, and due to the good quality and moderate environmental impact, these products are almost always sold out. Mechanical recycling, on the other hand, is the most attractive in environmental terms, but has the most variable quality.
I think that all technologies have a place somewhere in medical technology. But the key takeaway must be that we use recyclates to reduce CO2. And, of course, it also depends on the risk of the medical device in question. A walking aid made from mechanical recyclate is possible. In the case of an infusion set, chemical or solvent-based recycling is more likely to be used.
What future prospects do you see for recyclates in medical technology?
Pianegonda: In my opinion, recyclates have a lot of untapped potential, as there are only a few recycled plastic applications in medical technology. At the moment, the sustainable products that are coming onto the market tend to be mass-balanced bio-based plastics. However, I think that recyclates definitely have potential. They make things a little more difficult in terms of quality and risk management, but in principle they have a lot of environmental advantages.
How do you think the medical technology industry can contribute to achieving sustainability goals in general?
Pianegonda: The global environmental impact of medical technology and the healthcare sector is 4.4 percent on average; depending on the country, this figure varies between 4 and 7 percent. So there is definitely leverage here to achieve the sustainability goals. In principle, the first thing to do is to avoid unnecessary things: unnecessary use of medical products, unnecessary operations, unnecessary days in hospital.
Furthermore, it is important to develop sustainable products. 80 percent of the environmental impact is defined during product development. Ecodesign guidelines can achieve a relatively large amount here, as the aim is to design products optimally, use as little material as possible, select the material with the best environmental impact and design the products in such a way that they can also be recycled. The medical technology industry can certainly make a contribution to greater sustainability here.
Kyra Molinari (Editorial team K-Mag)